CN104840443B - The pharmaceutical composition of the Pregabalin containing active ingredient - Google Patents
The pharmaceutical composition of the Pregabalin containing active ingredient Download PDFInfo
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- CN104840443B CN104840443B CN201510275818.9A CN201510275818A CN104840443B CN 104840443 B CN104840443 B CN 104840443B CN 201510275818 A CN201510275818 A CN 201510275818A CN 104840443 B CN104840443 B CN 104840443B
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Abstract
The invention belongs to field of pharmaceutical preparations, more particularly to a kind of slow released pregabalin medicine composition, include active ingredient and excipient, active ingredient is Pregabalin or its pharmaceutically acceptable salt, excipient includes matrix formers and sweller, matrix formers are polyvinyl acetate and the mixture of polyvinylpyrrolidone, and sweller is selected from one of Ac-Di-Sol, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, polyoxyethylene or its any combination.The pharmaceutical composition of the present invention, it is adapted to daily take orally once, reduce times for spraying, blood concentration peak valley ratio is reduced, while by selecting suitable sweller, Entogastric lingering can not only be reached, the stability problem that can also avoid peroxide from bringing, the stability of product is improved, medication daily is realized and once can reach therapeutic effect, with quick releasing formulation bioequivalence.The pharmaceutical composition of the present invention is mainly used for treating epilepsy, neuropathic pain etc..
Description
Technical field
The invention belongs to technical field of medicine.More particularly to a kind of mouth for the stabilization that can improve gastric transit time
Medication compositions, are adapted to daily once.
Background technology
Pregabalin and α in central nervous system2There is height in-δ sites (ancillary subunit of valtage-gated calcium channel)
Affinity is spent, and the relevant endogenous inhibiting nerve of adjusting being related to brain neuronal activity transmits matter gaba
(GABA) it is related.Pregabalin has antiseizure activity, and suitable for treating following illness：Epilepsy, herpes neuralgia etc..
Pregabalin capsule is quick releasing formulation, and usage bestows patient for daily 2 or 3 times during treatment for above indication.For
For the patient for needing Long-term taking medicine, QD, which takes medicine, can improve the compliance of patient.Daily medication once can also reduce medicine in blood
Cmax in liquid and potential, the undesirable side effect related with dosage is alleviated or avoided, can also be by increasing in blood plasma
Least concentration Cmin and increase efficacy of drugs.
Clinical research shows that Pregabalin is can absorb in the small intestine and the colon ascendens of the mankind, but less outside hepatic flexure of colon
Absorb, show when the average absorption window of Pregabalin is averagely about 6 small or shorter, daily multiple dosing, the blood of medicine can be caused
Concentration produces obvious fluctuation, it is necessary to which frequent drug administration is to keep the blood concentration of quite stable.The effective dose of Pregabalin is
150-600mg/ days, given with divided dose.Pregabalin capsule is taken 3 times daily, and medicine blood concentration can be caused rapid
Rise, then since drug distribution, metabolism and excretion, drug concentration reduce rapidly.So the utilization ratio of drug of quick releasing formulation compared with
It is low.General sustained release preparation technique effect is undesirable, the holdup time of tablet under one's belt is improved, so that improving the absorption of medicine is
A preferable thinking.
Patent CN101330907 is similarly the sustained release drug administration composition daily once containing Pregabalin, the patent
Sweller is only limited to use crospovidone to reach tablet expansion effect.It is fine with cross-linked carboxymethyl to compared for crospovidone
The tablet swelliong power of the plain sodium of dimension, the results showed that Ac-Di-Sol is with crospovidone in tablet longitudinal dilatation ability
Upper close, lateral expansion ability Ac-Di-Sol is better than crospovidone, with reference to the piece shape of this product, is preferably crosslinked
Sodium carboxymethylcellulose, meanwhile, crospovidone contains peroxide in itself, and there are stability risk for the composition of formation.
The content of the invention
The present invention provides a kind of pharmaceutical composition containing Pregabalin, is adapted to take orally once daily, reduces times for spraying, drop
Low blood concentration peak valley ratio, while by selecting suitable sweller, Entogastric lingering can not only be reached, it can also avoid peroxidating
The stability problem that thing is brought, improves the stability of product, while realizes medication daily and once can reach therapeutic effect,
With quick releasing formulation bioequivalence.Release Mechanisms are：This composition contact aqueous medium can fast volume expansion, extend tablet in stomach
The middle holdup time, by sustained-release matrix material, delays Slow release, improves drug absorption, reduce medicining times.
This pharmaceutical composition enters in stomach by oral administration, and after contacting gastric juice, quick water swelling, extends the gastric emptying time, and
Sustained release activity component, finally, pharmaceutical composition leave stomach and enter small intestine, the sustained release Pregabalin in small intestine.Prolong
Release time of the long acting component in stomach can effectively widen is administered relevant absorption window with quick-release, so as to allow QD to be administered.
A kind of pharmaceutical composition of the present invention, comprising active ingredient and excipient, the active ingredient for Pregabalin or
Its pharmaceutically acceptable salt, excipient include matrix formers and sweller, and the matrix formers are polyvinyl acetate
With the mixture of polyvinylpyrrolidone, the sweller is selected from Ac-Di-Sol, sodium carboxymethyl starch, low substitution
One of hydroxypropylcellulose, polyoxyethylene or its any combination.
Matrix formers polyvinyl acetate povidone mixture in the present invention, is 1- ethenyl-pyrrolidine -2- ketone
Homopolymer, molecular weight Mw are typically about 1 × 103To about 1 × 107, about 2.5 × 103To about 3 × 106Or about 1 × 104To about 1 ×
105.The polymer is purchased from BASF, its trade name KOLLIDON SR.The polymer is polyvinyl acetate and povidone with 8:
The spray drying physics mixture of 2 ratios mixing.It is poly- with 19% containing 80% polyvinyl acetate (molecular weight Mw is about 450000)
Ketone K30. is tieed up separately containing about 0.8% lauryl sodium sulfate and about 0.6% silica as stabilizer.The matrix formers
Insoluble drug release can be adjusted to a certain extent, available for adjustment sheet weight.
Wherein described sweller runs into aqueous medium for water-soluble or insoluble polymer, the sweller, can be quick
Water suction enables volume to expand rapidly, so that whole tablet volume increases, reaches the effect of Entogastric lingering.And sweller may be used also
With for example, by producing passage or influencing drug release rate by forming hydrophilic colloid.Sweller species is different, it is swollen
Effect has difference, and the degrees of expansion for being embodied in tablet whole volume, transverse direction, longitudinal direction etc. has more apparent difference, with reference to this production
The tablet shape of product and the Swelling Capacity of sweller, prioritizing selection Ac-Di-Sol, is purchased from German JRS, commodity
Entitled VIVASOL；Also U.S. FMC, trade name Ad-Di-Sol are purchased from.
Sweller as same effect has low-substituted hydroxypropyl cellulose, its not soluble in water and alcohol, but swellable.It is purchased from
The L-HPC LH-11 of Shin Etsu.Sodium carboxymethyl starch is starch carboxy methylation ether sodium salt, there is three grades, A, B, C, difference
It is the content of sodium, is purchased from the Explotab of the Primojel or JRS of Avebe.
Another sweller polyoxyethylene in said composition, has various grades, trade name POLYOX according to molecular weight.
Polyoxyethylene is the homopolymer of ethylene oxide, its molecular weight is usually 1 × 105To about 1 × 107Or about 1 × 106To about 1 × 107。
The sweller of 5%-30% is preferably comprised in composition.
The present invention pharmaceutical composition, wherein mass percent of the active ingredient in pharmaceutical composition for 2% to
60%, preferably 7-30%；Mass percent of the matrix formers in pharmaceutical composition is 10% to 70%, preferably 20-50%,
Most preferably 20-35%；Mass percent of the sweller in pharmaceutical composition is 15% to 50%.
In general, the amount for being added to the active ingredient of said composition is 25-600mg, preferably 80-300mg.
In the pharmaceutical composition of the present invention, contain two or more phases, it is preferable that wherein at least one mutually contains
At least following substances are as excipient：(1) polyvinyl acetate and the mixture of povidone, its ratio are the 20- of composition
50%/piece；(2) Ac-Di-Sol, its ratio are 15-50%/pieces of composition；(3) carbomer, its ratio are groups
1-10%/piece of compound；(4) polyoxyethylene, its ratio are 5-30%/pieces of composition.
The present invention pharmaceutical composition, the polyoxyethylene be selected from N750,205, N12K, N60K, 301, COAGULANT,
One of 303 or any two kinds of combination.Preferably, the polyoxyethylene is the N60K or 301 and 5%- of 5%-20%/piece
The combination of the N12K or N750 of 20%/piece；Alternatively, the polyoxyethylene is the COAGULANT of 5%-15%/piece.
In addition to matrix formers and sweller, pharmaceutical composition of the invention, also comprising lubricant and gelling agent, can change
Become the release characteristics of medicine.Wherein lubricant is selected from one of magnesium stearate, talcum powder, rilanit special or any combination, preferably
Magnesium stearate.Gelling agent, also referred to as hydrophilic colloid, when contacted, which can form cementitious mixtures, delay medicine to pass through
The diffusion of formulation, so as to extend by the time of formulation release medicine.The general gelling agent account for the 1% of composition total weight to
20%, preferably from about 1% to 10%.Gelling agent is selected from carbomer, polysaccharide or both combination, preferably carbomer, wherein the polysaccharide
Selected from one of xanthans, inulin, guar gum, carob and carrageenan or any combination.
Carbomer is bonded the high molecular polymer of allyl sucrose or pentaerythrite allyl ether for acrylic acid.Based on dry product
Calculate, (- COOH) containing carboxylic acid group should be 56.0%~68.0%.For example Carbopol 971 or Carbopol 71G may be selected.
Said composition can also contain the production required any appropriate excipient of tablet, such as：It is solvable or insoluble
Diluent (lactose, microcrystalline cellulose, mannitol etc.)；Lubricant (magnesium stearate, talcum powder, rilanit special etc.) and help
Flow agent (silica etc.).
Using common production technology, this can be produced by direct pressed powder or by dry press granule-making and then tabletting
The tablet of invention.Tablet hardness can obtain the tablet of some strength qualification friability in 200-300N.Tablet mould has certain
Specification, tablet meet gastric juice and expand at least 9 millimeters.Under the hardness, tablet delays Slow release.
Brief description of the drawings
Fig. 1 is that release profiles of the embodiment of the present invention 1-3 in 0.06N hydrochloric acid solutions grind the ginseng drawn in patent with former
According to curve release conditions comparison diagram；
Fig. 2 is that release profiles of the embodiment of the present invention 4-6 in 0.06N hydrochloric acid solutions grind the ginseng drawn in patent with former
According to curve release conditions comparison diagram；
Fig. 3 is that release profiles of the embodiment of the present invention 7-9 in 0.06N hydrochloric acid solutions grind the ginseng drawn in patent with former
According to curve release conditions comparison diagram.
Embodiment
The present invention is described in further details with reference to embodiment, but not limited to this.
Preparation of the batch for the tablet of 1kg this products is carried out in laboratory equipment, raw material selection and preparation method are as follows.
Pregabalin raw material meets correlated quality requirement, and inert matter is respectively matrix formers：Cross-linked carboxymethyl is fine
The plain sodium of dimension, Meier father and son Co., Ltd is stepped on purchased from Germany is auspicious；Sweller：Ac-Di-Sol, purchased from German BASF；
Sweller：Polyoxyethylene N60K and N12K, purchased from Shanghai Ka Lekang；Gelling agent：Carbomer, it is limited purchased from Lu Borun special type chemical industry
Company；Lubricant：Magnesium stearate, purchased from Distributions in Liaocheng of Shandong Province A Hua.
The supplementary material in addition to magnesium stearate is mixed in 5L three-dimensional hopper mixers, time 5min, 15 turns of rotating speed/
Minute can meet the mixing homogeneity of mixed powder.Magnesium stearate is crossed 40 mesh to be added in good supplementary material mixed above, continue with
Above parameter is mixed, 5 minutes.The mixed powder mixed is subjected to tabletting, hardness is 200 between 300N.Finally with
The happy health coating powder of 85F serial cards is coated, and is increased weight 3% or so.
Embodiment 1 to 9
Prescription one to nine (corresponding respectively to embodiment 1 to 9) in table 1,2,3 represents to contain Pregabalin and various figurations
The composition of the laboratory scale of agent, table 4 represent the external dilation and release behavior of above-mentioned composition.Table 5 shows the reality
Apply the stability (percentage composition of major impurity lactams) of example.For above example, by all groups in addition to magnesium stearate
Divide and mixed in hopper mixer, and reach certain mixing uniformity；Then magnesium stearate is crossed 40 mesh sieves to enter, then into
Row mixing, tabletted weight is the tablet of 1125mg under 200-300N hardness.
Pharmaceutical composition of the table 1 containing Pregabalin
| Composition | Prescription one (mg/ pieces) | Prescription two (mg/ pieces) | Prescription three (mg/ pieces) |
| Pregabalin | 75 | 75 | 75 |
| Polyvinyl acetate povidone mixture | 200 | 345 | 500 |
| Ac-Di-Sol | 550 | 400 | 200 |
| Polyoxyethylene N60K | 120 | 120 | 290 |
| Polyoxyethylene N12K | 60 | 150 | 0 |
| Carbomer | 110 | 25 | 50 |
| Magnesium stearate | 10 | 10 | 10 |
| Piece weight | 1125 | 1125 | 1125 |
Pharmaceutical composition of the table 2 containing Pregabalin
| Composition | Prescription four (mg/ pieces) | Prescription five (mg/ pieces) | Prescription six (mg/ pieces) |
| Pregabalin | 150 | 150 | 150 |
| Polyvinyl acetate povidone mixture | 200 | 355 | 500 |
| Ac-Di-Sol | 500 | 325 | 200 |
| Polyoxyethylene N60K | 120 | 100 | 180 |
| Polyoxyethylene N12K | 65 | 125 | 35 |
| Carbomer | 80 | 60 | 50 |
| Magnesium stearate | 10 | 10 | 10 |
| Piece weight | 1125 | 1125 | 1125 |
Pharmaceutical composition of the table 3 containing Pregabalin
| Composition | Prescription seven (mg/ pieces) | Prescription eight (mg/ pieces) | Prescription nine (mg/ pieces) |
| Pregabalin | 300 | 300 | 300 |
| Polyvinyl acetate povidone mixture | 250 | 300 | 200 |
| Ac-Di-Sol | 270 | 300 | 250 |
| Polyoxyethylene N60K | 100 | 120 | 250 |
| Polyoxyethylene N12K | 0 | 25 | 65 |
| Carbomer | 195 | 70 | 50 |
| Magnesium stearate | 10 | 10 | 10 |
| Piece weight | 1125 | 1125 | 1125 |
Tablet dilation
The speed of tablet volumetric expansion is measured at 37 DEG C of II devices of USP in 0.06N hydrochloric acid solutions.Its length of physical measure
Degree, width and thickness, measurement point is respectively 0.5h, 1h, 2h and 6h, as a result such as table 4.
The external dilatancy of pharmaceutical composition of the table 4 containing Pregabalin
In 0.06N hydrochloric acid solutions, 50 turns of slurry processes are measured.
By the measurement result of table 4, the medicine in the embodiment of the present invention 1-9 is respectively provided with stronger swellability, makes
Obtain medicine to enter in stomach, rapid expanding, the holdup time is possibly realized under one's belt for raising.
Tablet stability
The tablet of preparation is placed in HDPE bottles interior plus one bag of (specification of silica-gel desiccant：2.0g/ bags), it is put in 30 ± 2 DEG C
Under 65 ± 5% relative humidity, stability test is carried out.Sample point is respectively 1 month, 2 months and 3 months, uses HPLC points
Pregabalin content and lactam content are analysed, the results are shown in Table 5.
5 embodiment stability data of table --- the percentage composition of impurity lactams
| 0 day | 1 month | 2 months | 3 months | |
| Prescription one | 0.05 | 0.12 | 0.17 | 0.24 |
| Prescription two | 0.04 | 0.11 | 0.16 | 0.24 |
| Prescription three | 0.05 | 0.12 | 0.17 | 0.24 |
| Prescription four | 0.03 | 0.11 | 0.13 | 0.16 |
| Prescription five | 0.05 | 0.10 | 0.10 | 0.16 |
| Prescription six | 0.04 | 0.12 | 0.12 | 0.15 |
| Prescription seven | 0.03 | 0.09 | 0.12 | 0.15 |
| Prescription eight | 0.04 | 0.08 | 0.12 | 0.15 |
| Prescription nine | 0.04 | 0.07 | 0.12 | 0.11 |
By the stability data of table 5, excipient has preferable compatibility, energy with active ingredient selected by the present invention
Enough ensure the stability of product.
Original grind patent CN101330907 authorize text in [0198] section to [0205] section to the external of slow released pregabalin piece
Release has carried out related text description, and the present inventor carries out curve simulation to it, obtains the former In-vitro release curves for grinding patent
(with reference to curve), and release profiles of the product of the embodiment of the present invention one to nine in 0.06N hydrochloric acid solutions are carried out with it
Contrast, as a result such as Fig. 1-3.
The release profiles of Fig. 1-3 show the present invention composition can effective Drug controlled release, reach slow release effect.Together
When compare with the In-vitro release curves that grind described in patent CN101330907 of original, the results showed that both release profiles are similar, reduce
Bioequivalence risk, improves product stability.
Non-clinical Pharmacokinetics are tested
The exploitation of slow released pregabalin piece is intended to reduce the administration number of times of Pregabalin capsule, reduces the peak valley of blood concentration
Than, mitigate poisonous side effect of medicine, while above all reach both bioequivalences, therefore present inventor has performed Pregabalin
Capsule and self-control sustained release tablets pharmacokinetic in cynomolgus monkey.
Experiment is originally designed for the administration of two cycle dual crossings, and establishes LC-MS/ of the Pregabalin in machin blood plasma
MS quantitative analysis methods, and systems approach verification has been carried out, analysis method meets the related specifications of Determination of Biological Samples.Use
WinNonlin softwares (6.3 editions) calculate pharmacokinetic parameter according to non-compartment model, using t methods of inspection to plasma exposure amount
(AUC) statistical analysis is carried out.
Detailed pharmacokinetic parameter, statistical result and Drug-time curve refer to table 6.
6 machin of table takes orally the pharmacokinetic parameter of Pregabalin Pregabalin after by test preparation and reference preparation
The statistical result of (AUC through dose modification)
a:AUCadjust=AUCmean/ Dose, b:P>0.05 represents that there was no significant difference, c:F%=AUC0-t
adjust(T)/AUC0-tadjust(R)；
Experimental result shows that machin takes orally the product slow released pregabalin piece for giving the present invention under the conditions of high fat breakfast
AUC after (by test preparation) takes orally to give in fasted condition with machin has listed Pregabalin capsule (reference preparation, commodity
Name " diazepam ", Pfizer company) AUC compare, without notable significant difference.Pregabalin is by test preparation relative to reference
Preparation bioavilability is 118.99%.
Machin takes orally the AUC after giving product slow released pregabalin piece of the invention and exists with machin in fasted condition
Take orally to give under fasted conditions and listed the AUC of Pregabalin capsule and compare, without notable significant difference.Pregabalin is manufactured experimently
Agent is 108.16% relative to reference preparation bioavilability.
Slow released pregabalin piece is no matter under the conditions of empty stomach or high fat breakfast, Cmax 30% left sides lower than reference preparation
The right side, prompts sustained release tablets to be likely to decrease the security that peak valley effect is brought to a certain extent while validity is not influenced
Worry.In addition, taking a blood sample after 12h is administered to last, blood concentration of the sustained release tablets under two kinds for the treatment of conditions is compared with reference system
Agent is high, prompts the duration that sustained release tablets maintain effective blood drug concentration to be grown compared with reference preparation, this point also props up to a certain extent
Longer cycle administration during having held sustained release tablets clinic.
Claims (12)
1. a kind of pharmaceutical composition, comprising active ingredient and excipient, the active ingredient is Pregabalin or it pharmaceutically may be used
The salt of receiving, excipient include matrix formers and sweller, and the matrix formers are polyvinyl acetate and polyethylene pyrrole
The mixture of pyrrolidone, the sweller are selected from Ac-Di-Sol, sodium carboxymethyl starch, low-substituted hydroxypropyl fiber
One of element, polyoxyethylene or its any combination；
Said composition contains following substances as excipient：
(1) polyvinyl acetate and the mixture of povidone, its ratio are 20-50%/pieces of composition；
(2) Ac-Di-Sol, its ratio are 15-50%/pieces of composition；
(3) carbomer, its ratio are 1-10%/pieces of composition；
(4) polyoxyethylene, its ratio are 5-30%/pieces of composition.
2. pharmaceutical composition according to claim 1, wherein quality percentage of the active ingredient in pharmaceutical composition
Than for 2% to 60%.
3. pharmaceutical composition according to claim 2, wherein quality percentage of the active ingredient in pharmaceutical composition
Than for 7-30%.
4. pharmaceutical composition according to claim 3, wherein quality hundred of the matrix formers in pharmaceutical composition
It is 20-35% to divide ratio.
5. pharmaceutical composition according to claim 1, it is characterised in that the polyoxyethylene be selected from N750,205, N12K,
N60K, 301, COAGULANT, one of 303 or any two kinds of combination.
6. pharmaceutical composition according to claim 1, it is characterised in that the polyoxyethylene is 5%-20%/piece
The combination of N60K or 301 and the N12K or N750 of 5%-20%/piece, or the COAGULANT for 5%-15%/piece.
7. pharmaceutical composition according to claim 1, it is characterised in that the pharmaceutical composition also includes lubricant, lubrication
Agent is selected from one of magnesium stearate, talcum powder, rilanit special or any combination.
8. pharmaceutical composition according to claim 7, it is characterised in that the lubricant is selected from magnesium stearate.
Tablet volume when 9. pharmaceutical composition according to claim 1, wherein described pharmaceutical composition contact aqueous medium
It is expanded to about 9 millimeters or larger size.
10. pharmaceutical composition according to claim 1, said composition can be detained 3 hours to 14 after taking orally in patient's stomach
Hour.
11. pharmaceutical composition according to claim 1, said composition is used to treat epilepsy, herpes neuralgia.
12. pharmaceutical composition according to claim 1, said composition take orally, once a day.
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Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106606495A (en) * | 2015-10-27 | 2017-05-03 | 四川海思科制药有限公司 | Pregabalin sustained-release tablet medicinal composition and preparation method thereof |
| CN107998074A (en) * | 2017-12-13 | 2018-05-08 | 广州大光制药有限公司 | Pregabalin oral administration solution and preparation method thereof |
| US11938222B2 (en) | 2018-06-13 | 2024-03-26 | Beijing Tide Pharmaceutical Co., Ltd. | Pregabalin sustained release composition and method for preparing the same |
| CN111053749B (en) * | 2018-10-16 | 2022-07-15 | 北京泰德制药股份有限公司 | Pregabalin sustained-release composition and preparation method thereof |
| CN110585153A (en) * | 2018-06-13 | 2019-12-20 | 北京泰德制药股份有限公司 | Pregabalin sustained-release composition and preparation method thereof |
| CN110974798A (en) * | 2019-12-19 | 2020-04-10 | 江苏优仿医药科技有限公司 | Pharmaceutical composition, sustained-release tablet and preparation method thereof |
| TWI733299B (en) * | 2020-01-07 | 2021-07-11 | 華宇藥品股份有限公司 | Sustained-release formulation of pregabalin |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101011393A (en) * | 2007-02-16 | 2007-08-08 | 广州贝氏药业有限公司 | Irbesartan gastric retention sustained-release pharmaceutical composition |
| CN101330907A (en) * | 2005-11-02 | 2008-12-24 | 辉瑞产品公司 | Solid oral pharmaceutical compositions for once daily dosing containing pregabalin, a matrix forming agent and a swelling agent |
| CN103702664A (en) * | 2011-07-26 | 2014-04-02 | 柳韩洋行 | Sustained release tablet comprising pregabalin through two-phase release-controlling system |
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2015
- 2015-05-27 CN CN201510275818.9A patent/CN104840443B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101330907A (en) * | 2005-11-02 | 2008-12-24 | 辉瑞产品公司 | Solid oral pharmaceutical compositions for once daily dosing containing pregabalin, a matrix forming agent and a swelling agent |
| CN101011393A (en) * | 2007-02-16 | 2007-08-08 | 广州贝氏药业有限公司 | Irbesartan gastric retention sustained-release pharmaceutical composition |
| CN103702664A (en) * | 2011-07-26 | 2014-04-02 | 柳韩洋行 | Sustained release tablet comprising pregabalin through two-phase release-controlling system |
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